This study evaluates the effect of platelet-rich plasma (PRP) use during needling of the
      extensor carpalis radialis brevis tendon, after failure of proper reeducation including focal
      extra-corporal shockwave therapy (ESWT). Half of the patients with receive PRP and needling,
      and half of the patients will receive needling alone.

      During the reeducation, the clinical evaluation will be monitored and reported as in a case
      series.

ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation

Tennis Elbow

Tendinopathy

Tendinosis

Extracorporal Shockwave Therapy (ESWT)

Tendon Needling (Peppering)

Extensor Carpi Radialis Brevis (ECRB)

The conservative management of lateral epicondylitis is known to be a difficult-to-treat
      annoying condition. The first-line conservative management includes physical therapies with
      adjuvant painkillers and orthotics, and usually extracorporal shockwave therapy (ESWT). In
      clinical practice, infiltrative therapies a performed either before or after shockwave
      therapies. In the author's point of view, they represent a second-line conservative
      treatment.

      The success rate of ESWT for lateral epicondylitis depends mainly of the protocol used.
      Especially, poor results were observed with too low energy. Both radial and focal ESWT are
      effective, and focal ESWT has been showed as being as effective as surgical tenotomy.

      Concerning infiltrative therapies, it has been well established that corticosteroids are
      efficient in short-term but deleterious in long-term, likely for degenerative purposes.
      Prolotherapy, autologous blood, and botulinic toxin injections and others infiltrative
      therapies are less studied and therefore nowadays not clearly supported by the literature.
      Stem cells might be an alternative in the future.

      Platelet-rich-plasma (PRP) is nowadays widely used, but the results of clinical trials are
      discordant. Even if the superiority of PRP over corticosteroids is well established, the
      superiority of PRP on tendon needling or peppering is still controversial. Martin et al. 2019
      found in a partially blinded randomized controlled trial (RCT) involving 71 patients no
      clinical differences at 6 months of follow-up between 2 sessions of peppering with saline +
      local anesthetic and PRP + local anesthetic. In a similar unblended RCT involving 50
      patients, Schöffl et al. 2017 found no clinical differences at 6 months of follow-up.
      Montalvan et al. 2016 found in a RCT involving 50 patients between 2 infiltrations of PRP and
      saline no clinical differences at 6 months of follow-up. Rehabilitation was not allowed
      during the trial and the tendon was not peppered. Mishra et al. found in a blinded RCT
      involving 119 patients a positive clinical effect of PRP on saline solution, using a single
      injection with peppering. Behera et al. found similar results in a small RCT on 25 patients.

      Some factors has been advocated to influence the outcomes. The most relevant are: direct
      mechanic action of the needle and fenestration (peppering) technique, number of PRP
      injections, cells count (platelets, white blood- and red blood cells), activation of the
      platelets, concomitant local anesthetic use, peri-interventional use of NSAIDs and
      corticosteroids, concomitant rehabilitation or a contraria immobilization. Whether the
      positive results observed into the previous selected studies are due to either PRP,
      peppering, or any of the confounding factors described above remains to debate.

      The first aim of this study is to determine the proportion of patients, which would need an
      infiltrative technique after a proper rehabilitation protocol involving physical therapies,
      orthotics and ESWT. Our second aim is to establish whether PRP as adjuvant therapy to
      peppering would increase clinical outcomes.

      Details of sample size calculation (58 overall, 29 per group):

      58 patients are required to have a 95% chance of detecting, as significant at the 5% level,
      an increase in the primary outcome measure from 50 in the control group to 60 in the
      experimental group, considering a standard deviation of 10% and a dropout rate of 10%. After
      the inclusion of 40 patients, the standard deviation will be re-evaluated and the sample size
      corrected accordingly if necessary.

Initial rehabilitation protocol

Needling with PRP

Needling with saline solution

Tennis Elbow, Randomized Study: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation

Pain is evaluated on a 0-10 scale (0 = no pain) during isometric contraction maneuver of the ECRB

Independent physician

Pain is evaluated on a 0-10 scale (0 = no pain)

Function is evaluated on a 0-100% scale (100 = good function)

Score going from 0 to 100 (0 = good outcome)

Grip strength measured in Kg (Higher strength = better outcome)

Descriptive statistics: Evaluation of the proportion of patients for which the tendon needling is not necessary

Descriptive statistics: Quantity of PRP prepared (in ml)

Descriptive statistics: Quantity of PRP (or saline solution) injected (in ml)

The tridimensional volume of the lesion is measured in mm^3

The Doppler reaction will be evaluated on a subjective scale (none, mild, average, high, huge)

During active contraction of the ECRB, an eventual solution of continuity will be measured in mm

The thickness of the common epitrochlear will be measured in mm

The presence or absence of compressibility of the common epitrochlear tendon (binary outcome)

The patient pain on sonopalpation will be evaluated on a 0-10 scale (0= no pain)

First step: rehabilitation protocol during 3 months including focal shockwave therapy
Second step: one single tendon needling with PRP

First step: rehabilitation protocol during 3 months including focal shockwave therapy
Second step: one single tendon needling with Saline solution

ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?